GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Azithromycin for Injection USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Azithromycin for Injection USP 500mg
a) Each vial contains:
Azithromycin USP
Eq to Azithromycin (Anhydrous)………500mg
Excipients………………………………………q.s.
b) This pack is also contains:
Sterile Water for Injection USP……… 5ml

THERAPEUTIC INDICATIONS:

Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.

DIRECTION OF USE:

Constitute with 100mg/ml with 4.8ml of Sterile Water for Injection USP.
When reconstituted this product maintains its potency for 24 hours at room temperature.
For appropriate diluents and storage recommendations, refer to prescribing information.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Must be further diluted before use.
Warning: To be sold by retail with the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F)
Keep all medicines out of reach of children.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Dosage: As directed by the Physician.

Azithromycin for Injection USP 500mg Technical Specification:

Product Name:Azithromycin for Injection USP
Brand Name:Generic
Strength:500mg
Dosage Form:Lyophilized Powder for Injection (Sterile, Nonpyrogenic)
Packing:1 Vial + WFI Tray
Route of Administration:For IV Infusion use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antibacterial, Anti-Infectives, Antibiotic(macrolide)
Indication: Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.
Storage:Store at 20°C to 25°C (68°F to 77°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Azithromycin for Injection USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Azithromycin for Injection USP 500mg
    a)Each vial contains:
    Azithromycin USP
    Eq to Azithromycin (Anhydrous)………500mg
    Excipients………………………………………q.s.b) This pack is also contains:
    Sterile Water for Injection USP……… 5ml

THERAPEUTIC INDICATIONS:

Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.

DIRECTION OF USE:

Constitute with 100mg/ml with 4.8ml of Sterile Water for Injection USP.
When reconstituted this product maintains its potency for 24 hours at room temperature.
For appropriate diluents and storage recommendations, refer to prescribing information.

CAUTION & Warning:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Must be further diluted before use.
Warning: To be sold by retail with the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F)
Keep all medicines out of reach of children.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

The choice of Taj Pharmaceuticals as a supplier for Azithromycin for Injection should be considered based on several critical factors that impact patient care. Healthcare professionals and institutions prioritize pharmaceutical companies that uphold stringent quality assurance standards and comply with regulatory approvals to ensure the safety and efficacy of medications. Reliable product availability and a steadfast supply chain are essential to meet the continuous demand for medications like Azithromycin for Injection. Competitive pricing is also vital for cost-effective healthcare delivery. Exceptional customer support, efficient communication, and timely deliveries contribute to a positive working relationship. A supplier’s track record and reputation within the industry, along with its commitment to research and development, further influence healthcare providers’ trust. Additionally, a focus on patient safety, including rigorous adverse event monitoring and reporting, enhances the overall healthcare experience. In evaluating Taj Pharmaceuticals or any other supplier, healthcare institutions carefully assess these factors to ensure they can provide high-quality and dependable pharmaceutical products for optimal patient care.

What is Azithromycin for Injection and its uses?

Azithromycin for Injection is a medication that contains the active ingredient azithromycin, which is a macrolide antibiotic. It is available in injectable form and is used for various medical purposes. Here are its primary uses:

  • Bacterial Infections: Azithromycin for Injection is primarily used to treat bacterial infections caused by susceptible organisms. It is effective against a wide range of bacteria, including those responsible for respiratory tract infections, skin and soft tissue infections, and sexually transmitted infections (STIs).
  • Respiratory Infections: It is commonly used to treat respiratory infections such as pneumonia, bronchitis, and sinusitis. Azithromycin is especially valuable in cases of atypical pneumonia caused by organisms like Mycoplasma pneumoniae or Chlamydophila pneumoniae.
  • Skin and Soft Tissue Infections: Azithromycin can be used to treat skin and soft tissue infections, including cellulitis, impetigo, and infected wounds. It helps control bacterial growth at the site of infection.
  • Sexually Transmitted Infections: Azithromycin is used to treat some sexually transmitted infections, such as chlamydia and gonorrhea. It is often prescribed as a single-dose treatment for these conditions.
  • Infections in Immunocompromised Patients: Azithromycin can be used as prophylaxis against certain infections in immunocompromised patients, such as those with HIV/AIDS. It helps prevent opportunistic infections.
  • Prevention of Endocarditis: In some cases, Azithromycin for Injection may be prescribed before dental or surgical procedures to prevent bacterial endocarditis in individuals with specific heart conditions.

It’s important to note that Azithromycin for Injection is typically administered in a healthcare setting by trained healthcare professionals, as it is available in intravenous (IV) form. The choice of this medication and its dosage will depend on the specific bacterial infection being treated and the patient’s individual medical condition. Azithromycin is valued for its broad spectrum of activity and its effectiveness in treating a variety of bacterial infections. However, it should be used judiciously to minimize the risk of antibiotic resistance.

How does Azithromycin for Injection Work?

Azithromycin for Injection works by inhibiting the growth and replication of susceptible bacteria. Its mechanism of action is similar to that of other macrolide antibiotics. Here’s how Azithromycin exerts its antibacterial effects:

  • Protein Synthesis Inhibition: Azithromycin interferes with the bacterial protein synthesis process, specifically targeting the bacterial ribosomes (the cellular structures responsible for building proteins). It binds to the 50S subunit of the bacterial ribosome, preventing the incorporation of amino acids into growing protein chains.
  • Preventing Translation: By binding to the ribosome, Azithromycin disrupts the elongation phase of protein synthesis. This prevents the bacteria from producing essential proteins necessary for their survival and reproduction.
  • Bacteriostatic or Bactericidal Effect: The overall effect of Azithromycin on bacteria can vary. In many cases, it exhibits a bacteriostatic effect, which means it inhibits bacterial growth and replication without directly killing the bacteria. This allows the host’s immune system to better handle and eliminate the weakened bacteria. However, in some situations and with certain bacterial strains, Azithromycin can also have a bactericidal effect, directly killing the bacteria.
  • Post-Antibiotic Effect: Azithromycin has a unique property called the post-antibiotic effect. Even after the medication has been cleared from the body, its inhibitory effects on bacterial protein synthesis may persist. This extended effect contributes to its effectiveness in treating infections with once-daily dosing.
  • Broad-Spectrum Activity: Azithromycin has a broad spectrum of activity, making it effective against a wide range of bacteria, including Gram-positive, Gram-negative, atypical, and intracellular bacteria. It is particularly useful in treating respiratory tract infections, skin and soft tissue infections, and sexually transmitted infections.

It’s important to note that Azithromycin for Injection should be used for bacterial infections caused by susceptible organisms and should only be prescribed by a healthcare professional. The choice of this antibiotic and its dosage is determined based on the specific bacterial infection being treated, as well as the patient’s medical history and any known antibiotic sensitivities. The proper use of antibiotics is essential to ensure effective treatment while minimizing the risk of antibiotic resistance.

Benefits and Side Effects of Azithromycin for Injection?

Azithromycin for Injection, like any medication, offers benefits for treating bacterial infections but may also be associated with certain side effects. Here are the benefits and potential side effects:

Benefits:

  • Broad-Spectrum Antibiotic: Azithromycin for Injection is effective against a wide range of bacteria, including Gram-positive, Gram-negative, atypical, and intracellular pathogens. This broad-spectrum activity makes it valuable for treating various bacterial infections.
  • Single-Dose Option: In some cases, Azithromycin can be administered as a single-dose treatment, simplifying the dosing regimen and improving patient compliance, particularly for sexually transmitted infections like chlamydia and gonorrhea.
  • Tissue Penetration: Azithromycin has excellent tissue penetration, allowing it to reach the site of infection effectively. This property is beneficial for treating respiratory tract infections, skin and soft tissue infections, and others.
  • Unique Pharmacokinetics: Azithromycin has a long half-life, which means it remains active in the body for an extended period after administration. This can result in a prolonged duration of action, making once-daily dosing possible.
  • Reduced Risk of Drug Interactions: Azithromycin has a lower potential for drug interactions compared to some other antibiotics, which can be advantageous for patients taking multiple medications.

Side Effects:

  • Gastrointestinal Disturbances: Common side effects of Azithromycin may include diarrhea, nausea, abdominal pain, and vomiting. These symptoms are typically mild and self-limiting.
  • Allergic Reactions: While rare, allergic reactions to Azithromycin can occur and may manifest as skin rash, itching, swelling, or more severe reactions like anaphylaxis. Any signs of an allergic reaction should be reported to a healthcare provider promptly.
  • Liver Function Abnormalities: In rare cases, Azithromycin may affect liver function, leading to elevated liver enzymes. This is more common in individuals with preexisting liver conditions.
  • Cardiac Arrhythmias: Azithromycin has been associated with an increased risk of certain cardiac arrhythmias, particularly in individuals with known heart conditions. Patients with a history of arrhythmias should be closely monitored.
  • Clostridium difficile Infection: Like many antibiotics, Azithromycin use can disrupt the balance of normal gut bacteria, potentially leading to Clostridium difficile-associated diarrhea, a severe and potentially life-threatening condition.
  • QT Prolongation: Azithromycin may prolong the QT interval on electrocardiograms, which can increase the risk of ventricular arrhythmias, especially in individuals with underlying cardiac issues.
  • Drug Resistance: The misuse or overuse of antibiotics like Azithromycin can contribute to the development of antibiotic resistance in bacteria, making infections more challenging to treat in the future.

It’s essential for healthcare providers to carefully assess the risk-benefit profile when prescribing Azithromycin for Injection, taking into account the specific bacterial infection, patient history, and potential contraindications or interactions with other medications. Patients should report any unusual or severe side effects to their healthcare provider promptly, and they should complete the full course of treatment as prescribed to ensure effective bacterial eradication.

Frequently Asked Questions About Azithromycin for Injection:

Certainly, here are some frequently asked questions (FAQs) about Azithromycin for Injection:

  1. What is Azithromycin for Injection?

Azithromycin for Injection is a medication that contains the active ingredient azithromycin, which is an antibiotic. It is available in injectable form and is used to treat bacterial infections.

  1. What types of bacterial infections can Azithromycin for Injection treat?

Azithromycin for Injection is effective against a wide range of bacterial infections, including respiratory tract infections, skin and soft tissue infections, sexually transmitted infections (STIs), and others. It is often prescribed for conditions such as pneumonia, bronchitis, sinusitis, and chlamydia.

  1. How is Azithromycin for Injection administered?

Azithromycin for Injection is typically administered intravenously (IV) by healthcare professionals in a clinical setting. The dosage and duration of treatment depend on the specific infection being treated and the patient’s medical condition.

  1. Is Azithromycin for Injection suitable for children and adults?

Azithromycin for Injection can be used in both pediatric and adult populations, but the dosage is adjusted based on the patient’s age, weight, and the nature of the infection.

  1. Are there any contraindications or situations where Azithromycin for Injection should not be used?

Azithromycin for Injection should be used with caution or avoided in individuals with known allergies to azithromycin or other macrolide antibiotics. Additionally, it may interact with certain medications, so it’s essential to inform your healthcare provider of any other drugs you are taking.

  1. Can Azithromycin for Injection be used during pregnancy and breastfeeding?

The use of Azithromycin for Injection during pregnancy and breastfeeding should be carefully considered by a healthcare provider, weighing the potential benefits against any potential risks to the mother and baby.

  1. How quickly does Azithromycin for Injection work to treat bacterial infections?

The onset of action varies depending on the specific infection and the individual’s response to the medication. Some people may experience improvement within a day or two, while others may take longer.

  1. What should I do if I miss a dose of Azithromycin for Injection?

If you miss a scheduled dose, contact your healthcare provider as soon as possible for guidance. It’s important to complete the full course of treatment as prescribed.

  1. Are there common side effects associated with Azithromycin for Injection?

Common side effects may include gastrointestinal symptoms like diarrhea, nausea, abdominal pain, and vomiting. However, individual reactions can vary.

  1. Can Azithromycin for Injection be used to treat viral infections like the common cold or flu?

No, Azithromycin for Injection is an antibiotic and is not effective against viral infections. It should only be used to treat bacterial infections as prescribed by a healthcare provider.

Always consult with a qualified healthcare provider for personalized information and guidance regarding Azithromycin for Injection, as individual circumstances and medical needs may vary.

As Azithromycin for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Azithromycin for Injection product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Azithromycin for Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Azithromycin for Injection, Taj Pharmaceuticals Limited to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274